Drugs

Pro-generic Group Seeks Legislation to Curb Brand Abuses

A group of healthcare stakeholders is urging the Senate Special Committee on Aging to take up legislation to curb the increasing use of restricted access programs by brand drug makers to block generic entry into the market. In a recent letter to committee leaders, the stakeholders complain that some brand companies have used FDA-mandated Risk Evaluation and Mitigation Strategies (REMS) restricted-distribution programs to deny manufacturers of generics and biosimilars access to product samples they need to obtain agency approval.

The stakeholders recommend a House of Representatives bill called the Fair Access for Safe and Timely (FAST) Generics Act (H.R. 2841) as model legislation for the Senate to consider. “The bill would establish clear processes that would facilitate the provision of product samples to generic manufacturers and prevent companies from denying the implementation of shared REMS programs,” according to the letter. “The bill also defines certain anticompetitive practices with respect to restricted access programs, thus closing the existing loophole around current REMS prohibitions.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome